Zelira's Zenivol™, the World's First Clinically Validated Cannabinoid Medication for Insomnia, Achieves Regulatory Approval in Germany

2022-07-22

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PHILADELPHIA, July 21, 2022 /PRNewswire/ -- Zelira Therapeutics Ltd (ASX: ZLD,OTC-QB: ZLDAF), a global leader in the research, development and commercialization of clinically validated cannabinoid medicines, is pleased to announce that its groundbreaking insomnia medication Zenivol™ has achieved formal approval from German regulatory authority BfArM to launch in the German medical cannabis market.

Zenivol™ is the world's first and only clinically validated, pharmaceutical-grade, cannabis-based sleep medication. Zenivol™'s clinical research achieved the highest level of scientific review when it was peer reviewed in the Journal of Sleep. It is currently available by prescription in Australia under the country's legal cannabis regulations.

"The formal approval of Zenivol™ by BfArM in Germany marks a major milestone for Zelira; Germany is one of the largest global markets for cannabinoid-based medicines, and also one of the highest quality global regulatory markets for pharmaceuticals," says Zelira CEO Dr. Oludare Odumosu. "We look forward to working with our partner, Adjupharm, in launching Zenivol™ in Germany and supporting patients and physicians in treating chronic insomnia in a safe and effective manner. With formal regulatory approval for Zenivol™ now received in Germany, we continue to progress activities to license Zenivol® into other global markets."

Zelira Therapeutics Ltd (ASX: ZLD,OTCQB: ZLDAF) is a leading global therapeutic medical cannabinoid company with access to the world's largest and fastest growing cannabinoid medicine markets. Zelira owns a portfolio of proprietary revenue generating products and a pipeline of candidates undergoing clinical development that are positioned to enter global markets.

The Company is focused on developing branded cannabinoid-based medicines for the treatment of a variety of medical conditions in its Rx business, including insomnia, autism and chronic non-cancer pain.

The Company has two proprietary formulations under the HOPE™ brand that are generating revenues in Australia, Pennsylvania and have been licensed in Louisiana and Washington D.C., with other states in the US expected to follow. Zelira is also generating revenue in Australia from its proprietary and patented Zenivol™, a leading cannabinoid-based medicine for treatment of chronic insomnia. Zenivol™ has successfully completed the world's first Phase 1b clinical trial for chronic insomnia where it was found to be a safe and effective treatment.

In 2020, Zelira partnered with SprinJene®Natural to develop and commercialize natural and organic oral care products under the SprinjeneCBD brand, as part of Zelira's OTC business. The SprinjeneCBD toothpaste product is the first of several scientifically formulated, hemp-derived, oral care products containing cannabinoids and based on the proprietary and patented technology of Blackseed oil and Zinc.

The Company conducts its work in partnership with world-leading researchers and organizations including Curtin University in Perth, Western Australia; the Telethon Kids Institute in Perth; the University of Western Australia, in Perth; St. Vincent's Hospital in Melbourne, Australia; and the Children's Hospital of Philadelphia (CHOP) in the United States.

Adjupharm GmbH has more than 30 years of experience as a service provider for the pharmaceutical industry. Since then, the range of products and services has expanded enormously to focus on contract manufacturing for importers of pharmaceuticals in the EU. Adjupharm's range of services include the production and marketing of pharmaceutical dietary supplements.

In 2018, Adjupharm began pioneering work in the cannabis sector in Germany and has all the relevant licenses for the contract manufacturing of medical cannabis. Adjupharm uses its experience in the manufacture of medical cannabis to deliver high quality products to pharmacies and pharmaceutical wholesalers. Adjupharm has been a subsidiary of International Medical Cannabis (IMC) since 2019 ( www.imcannabis.de/). It combines the best of Israel and Germany: a spirit of innovation, many years of know-how in the cannabis industry, state-of-the-art technologies, security and reliability in deliveries, knowledge of the German market and knowledge of the needs of patients.

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